Siemens Medical Solutions USA, Inc: Medical Device Recall in 2025 - (Recall #: Z-2020-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

interventional fluoroscopic x-ray system

Product Classification:

Class II

Date Initiated: May 15, 2025

Date Posted: July 9, 2025

Recall Number: Z-2020-2025

Event ID: 97135

Reason for Recall:

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

Status: Ongoing

Product Quantity:

Code Information:

4056869063317

Distribution Pattern:

Worldwide.

Voluntary or Mandated:

FDA Mandated